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The Effects of Non-invasive Brain Stimulation on Treatment Adherence in Schizophrenia

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ClinicalTrials.gov Identifier: NCT04033679
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Gerretsen, Centre for Addiction and Mental Health

Brief Summary:
This study seeks to explore the effects of transcranial direct current stimulation (tDCS), a non-invasive method of brain stimulation, as an adjunctive treatment to improve antipsychotic medication adherence in patients with schizophrenia (SCZ). The investigators hypothesize that 20 sessions of tDCS will improve medication nonadherence in patients with SCZ.

Condition or disease Intervention/treatment Phase
Schizophrenia;Schizoaffective Other: Active TDCS Other: Sham TDCS Not Applicable

Detailed Description:
The proposed study will investigate the effects of adjunctive tDCS on antipsychotic medication adherence by targeting brain regions implicated in impaired insight, a primary contributor to medication nonadherence in patients with SCZ. Participants will be randomized to receive either active or sham tDCS. tDCS will be administered twice-daily for 10 days (20 sessions) excluding weekends. Brain scans will be performed before and after 10 days of tDCS. Antipsychotic drug adherence will be assessed based primarily on pill-count, and secondarily, plasma level concentrations and clinician-judgement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participant randomly assigned to receive either TDCS stimulation or sham stimulation.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: The Effects of Adjunctive Transcranial Direct Current Stimulation on Treatment Adherence in Schizophrenia
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Active TDCS
In the active condition, a constant current of 2 mA intensity will be applied for 20 min to the parietal regions, using P3 as the cathode and P4 as the anode.
Other: Active TDCS
Participants will receive active TDCS stimulation.

Sham Comparator: Sham TDCS
In the sham condition, stimulation will be administered using the same parameters at the site of active treatment, but the current will be turned off after 30 seconds.
Other: Sham TDCS
Participants will receive sham TDCS stimulation.




Primary Outcome Measures :
  1. Medication adherence - Pill Count [ Time Frame: During 3-month follow up phase ]
    Pill count or percentage of weekly antipsychotic medication adherence will be assessed during the 3-month follow up phase after TDCS is completed.

  2. Medication adherence - Plasma Monitoring [ Time Frame: Blood concentration of antipsychotic medication will be measured on day of the first TDCS session before TDCS starts, after 1 week of TDCS is completed, after 2 weeks of TDCS are completed, and during the 3-month follow up phase. ]
    Blood concentrations of antipsychotic medication will be measured at different points in the study to assess medication adherence.

  3. Medication adherence - Clinician Rating [ Time Frame: During 3-month follow up phase ]
    The Clinician Adherence Rating Scale is a 7-point clinician rated measure which takes into account patients' self-report, medication adherence, and changes in plasma concentrations to provide a comprehensive assessment of antipsychotic medication adherence. A higher score represents greater adherence.


Secondary Outcome Measures :
  1. Insight into Psychosis [ Time Frame: Illness awareness will be assessed before the TDCS phase begins, after 2 weeks of TDCS are completed, and during the 3-month follow up period ]
    Level of illness awareness will be assessed by the VAGUS Insight into Psychosis scale. The VAGUS assesses the core domains of insight into psychosis. VAGUS has both self-report and clinician-rated versions with good inter-scale reliability and test-retest reliability. Higher scores indicate better insight into illness.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participants of any race or ethnicity
  2. Inpatients or outpatients ≥18 years of age
  3. DSM-V diagnosis of SCZ or schizoaffective disorder
  4. Capable of consenting to participate in the research study
  5. On a stable dose of aripiprazole or risperidone and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study

Exclusion Criteria:

  1. Unwilling or incapable to consent to the study based on the MacArthur Test of Competence
  2. Unstable medical or any concomitant major medical or neurological illness, including a history of seizures
  3. Acute suicidal or homicidal ideation
  4. Formal thought disorder rating ≥3 on the Positive and Negative Syndrome Scale (PANSS) P2 conceptual disorganization item
  5. DSM-V substance dependence (except caffeine and nicotine) within 1 month of entering the study*
  6. Positive urine drug screen at the screening visit
  7. Metal implants or pacemaker precluding an MRI scan or other contraindications to MRI (eg., claustrophobia)
  8. Pregnancy
  9. Score < 32 on the Wide Range Achievement Test-III

    • Substance misuse: In addition to impaired insight, substance misuse is one of the principle contributors to medication nonadherence. To minimize the possibility of its influence, participants with a DSM-V diagnosis of substance dependence within 1 month of entering the study or a positive urine drug test at the screening visit will be excluded. Substance use and urine drug screens will be assessed at subsequent study visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033679


Contacts
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Contact: Philip Gerretsen, MD, PhD 416-535-8501 ext 39426 philip.gerretsen@camh.ca
Contact: Ariel Graff, MD, PhD 416-535-8501 ext 34834 ariel.graff@camh.ca

Locations
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Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1R8
Contact: Philip Gerretsen, MD, PHD    416-535-8501 ext 39426    philip.gerretsen@camh.ca   
Contact: Ariel Graff, MD, PHD    416-535-8501 ext 34834    ariel.graff@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Philip Gerretsen, MD, PhD Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Philip Gerretsen, Clinicial Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04033679     History of Changes
Other Study ID Numbers: 103-2018
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Gerretsen, Centre for Addiction and Mental Health:
Magnetic resonance imaging
Brain stimulation
Medication adherence
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders